BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stansion Matrix®

    DI: M711C0810070 · Model: C081007 · Innovasis, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Stansion Matrix®
    Primary DI
    M711C0810070
    Version / Model
    C081007
    Catalog Number
    C081007
    Company Name
    Innovasis, Inc.
    Labeler DUNS
    156567492
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-04-15
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    5c164686-43b6-4a93-bff0-208970f966e5

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MQP Spinal Vertebral Body Replacement Device

    GMDN Terms

    Code Name
    57806 Vertebral body prosthesis, non-sterile

    Identifiers

    Type ID
    Primary M711C0810070

    Customer Contacts

    Phone
    801-261-2236
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K042600 000

    Device Sizes

    Type Value Unit Text
    Length 23 Millimeter
    Width 7 Millimeter
    Height 10 Millimeter